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Trial record 1 of 3 for:    HP184
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HP184 in Chronic Spinal Cord Injury Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00093275
Recruitment Status : Completed
First Posted : October 7, 2004
Last Update Posted : August 21, 2008
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Brief Summary:
The purpose of this study is to determine whether HP184 is effective in the treatment of chronic spinal cord injury (CSCI).

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Drug: HP184 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of HP184 Administered Orally Once Daily for Twenty-Four Weeks in Adult Subjects With Chronic Spinal Cord Injury (CSCI)
Study Start Date : October 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change from baseline in total motor score of American Spinal Injury Association (ASIA) manual motor test at Week 24.

Secondary Outcome Measures :
  1. Safety evaluation.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female subjects with incomplete (traumatic), chronic (defined as 18 months or more post spinal cord injury) SCI aged 18 to 65 years
  • CSCI must be categorized in classes C or D in the ASIA impairment scale. (C = Incomplete impairment with motor function preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3. D = Incomplete impairment with motor function preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade more than or equal to 3).
  • The level of the SCI must be between C4 and T10 (neurological)
  • Subject has a measurable range of motion at the hips, knees and ankles and possesses potential propulsive activity (i.e. no functional contractures)
  • Female subjects of childbearing potential (those who are not surgically sterile or who are less than 2 years postmenopausal) must be using two forms of birth control, including a primary and a secondary form and have a negative pregnancy test immediately prior to treatment. Primary forms of contraception include: tubal ligation, partner's vasectomy, intrauterine devices, birth control pills, and topical/injectable/implantable/insertable hormonal birth control products. Secondary forms of contraception include diaphragms, latex condoms and cervical caps; each must be used with a spermicide.

Exclusion Criteria:

  • Any clinical evidence of recent fracture(s) within the last six months prior to study start.
  • Any history of Multiple Sclerosis or peripheral demyelinating disease or neuromuscular disorder.
  • Heart rate of less than 38 or greater than 100
  • Ashworth spasticity score of 0/4 or 4/4 at the hip or knee.
  • Subject whose medical condition requires mechanical ventilation.
  • Lower motor neuron injury, such as those with conus medullaris or cauda equina injuries.
  • Subject with lower extremity amputation or proximal femorectomy.
  • Subject with pressure ulcers stages 3 and 4.
  • Subject medically or mentally unstable in judgment of Investigator.
  • Subject on tricyclic antidepressants such as nortriptyline, amitriptyline and imipramine.
  • Subject with ASIA motor score of greater than or equal to 92.
  • Subject with ASIA sensory score of greater than or equal to 200.
  • Subject with history of seizure within 2 years prior to study start.
  • Subjects who have participated in a clinical trial involving investigational medication within 30 days prior to administration of HP184 or placebo.
  • Female subjects with positive urine pregnancy test.
  • Female subjects who are breast feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00093275

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
sanofi-aventis administrative Australia & New-Zealand administrative office
Macquarie Park, New South Wales, Australia
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Mumbai, India
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi

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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00093275    
Other Study ID Numbers: DRI6213
First Posted: October 7, 2004    Key Record Dates
Last Update Posted: August 21, 2008
Last Verified: August 2008
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System